JPRN-UMIN000017628
Recruiting
Phase 3
A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial) - A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Japan Clinical Oncology Group (JCOG)0 sites300 target enrollmentMay 20, 2015
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- clinical stage I/II/III (excluding T4) thoracic esophageal cancer
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2\) Infectious disease with systemic therapy indicated. 3\) Body temperature of 38 or more degrees Celsius. 4\) Pregnancy, possible pregnancy, within 28 days after delivery or breast\-feeding. 5\) Severe psychiatric disease. 6\) Continuous systemic steroid or immune\-suppressive drug therapy. 7\) Unstable angina pectoris, or history of myocardial infarction within six months. 8\) Severe pulmonary fibrosis or emphysema. 9\) Poorly controlled hypertension. 10\) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Outcomes
Primary Outcomes
Not specified
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